Comparison of 10% Immunoglobulin Dosing Times for Kawasaki Disease

JRCT ID: jRCT1041230181

Registered date:29/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Kawasaki Disease
• Date of first enrollment: 29/03/2024
• Target sample size: 560
• Study type: Interventional
• Intervention(s): Dosing time of immunoglobulin

Outcome(s)

• Primary Outcome: Percentage of cases with fever resolution within 24 hours of starting immunoglobulin therapy
• Secondary Outcome: Time from start of first IVIG administration to fever resolution, number of patients requiring 2nd line therapy, time from initial IVIG to 2nd line therapy, frequency of initial treatment failure and relapse, side effects of IVIG, frequency of CAL complications within 28 days and at 28 days (+7 days or -7 days) of treatment

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 15age old
• Gender: Both

Include criteria

1) Children with a fever of 37.5 degrees or higher who have been diagnosed with Kawasaki disease. In addition, children who have relapsed 180 days after the last globulin administration are also eligible.
2) Children who have not started initial treatment. (15 years of age or younger)

• Exclude criteria: CAL at the start of treatment, history of steroids within 30 days and immunoglobulin within 180 days of starting treatment

Related Information

• Primary Sponsor: Sato Yoshiaki